Normast3 for Adults With Diabetic Polyneuropathy
ConditionDiabete Type 2
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of Roma La Sapienza
About this trial
The goal of this clinical trial is to find out if a new supplement called Normast® 3 can help reduce nerve pain and improve nerve function in adults with diabetic polyneuropathy (DPN). DPN is a common complication of diabetes that damages nerves, often causing burning, tingling, or stabbing pain, as well as problems with the autonomic nervous system, which controls things like sweating and heart rate.
The main questions this study aims to answer are:
Does taking Normast® 3 lower daily pain levels after 12 weeks of treatment? Does it improve the function of small nerve fibers and the autonomic nervous system compared with a placebo (a look-alike tablet with no active ingredients)? Study design This is a randomized, double-blind, placebo-controlled clinical trial. This means participants are randomly assigned to receive either Normast® 3 or placebo, and neither participants nor researchers will know who is receiving which treatment until the study ends.
Who can take part About 40 adults aged 18 to 80 who have diabetic polyneuropathy affecting both small and large nerve fibers will be enrolled. Participants must have stable diabetes treatment for at least 3 months and be able to take oral medication. People with other nerve diseases, major psychiatric conditions, or serious health problems will not be able to take part.
What participants will do Take Normast® 3 or placebo tablets twice a day for 12 weeks while continuing their usual treatments Complete pain and symptom questionnaires Have neurological examinations including quantitative sensory testing, heart and blood pressure tests, the dynamic sweat test, and small skin biopsies to look at intraepidermal nerve fibers Return for follow-up visits at 12 weeks (end of treatment) and 24 weeks (long-term follow-up) Safety and follow-up Researchers will check participants' safety through blood and urine tests and by monitoring any side effects. Participants can stop the study at any time.
Where the study takes place This study is being conducted at the Department of Human Neuroscience, Sapienza University of Rome (Italy).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Normast® 3 - a food for special medical purposes (FSMP) containing co-micronized palmitoylethanolamide (PEA) with rutin and hydroxytyrosol. It is designed to support the management of diabetic polyneu
Dietary supplementNormast® 3 is a food for special medical purposes (FSMP) containing co-micronized palmitoylethanolamide (PEA) with rutin (5:1) and hydroxytyrosol. Each tablet provides 360 mg PEA/rutin and 15 mg hydroxytyrosol. The product is formulated to target neuroinflammation and vascular dysfunction involved in diabetic polyneuropathy. In this study, participants will take one tablet twice daily (after lunch and after dinner) for 12 weeks, in addition to their standard diabetes care.
Placebo
Dietary supplementPlacebo tablets are visually and taste-matched to Normast® 3 but contain no active ingredients. Each tablet is composed of inert excipients (mainly microcrystalline cellulose and other standard tablet components). Participants will take one placebo tablet twice daily (after lunch and after dinner) for 12 weeks, in addition to their standard diabetes care.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Normast3Experimental treatment 1 intervention
Group B: placeboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in average daily pain intensity
Description: Change from baseline to Week 12 in the weekly average of participants' daily pain intensity scores, measured using the 0-10 Numeric Rating Scale (NRS), where 0 = no pain and 10 = worst possible pain. Safety Issue: No
Time frame
Time Frame: Baseline to Week 12Secondary outcomes
1
Change in autonomic system function (sweat glands) at Week 12
Percentage change from baseline in the number of activated sweat glands, assessed with sudomotor function testing (volume of sweat produced expressed as mcl/cm2/min), in the Normast® 3 group compared to the placebo group.
Time frame
Baseline to Week 122
Change in R-R variability at rest Week 12
Percentage change from baseline in R-R variability at rest after treatment (expressed as total heart rate variability power in milliseconds squared), comparing the Normast® 3 group to the placebo group.
Time frame
Baseline to Week 123
Change in autonomic innervation density at Week 12
Percentage change from baseline in piloerector muscle autonomic innervation density, measured by skin biopsy and immunostaining, in the Normast® 3 group compared to the placebo group.
Time frame
Baseline to Week 124
Change in autonomic system function (sweat glands) at Week 24
Percentage change from baseline in the number of activated sweat glands, assessed with sudomotor function testing (volume of sweat produced expressed as mcl/cm2/min), in the Normast® 3 group compared to the placebo group.
Time frame
Baseline to Week 24Other outcomes
1
Change in Patient Global Impression of Change (PGIC) at Week 12
Percentage of participants in the Normast® 3 group reporting an improvement of at least 2 points on the Patient Global Impression of Change (PGIC) (a 7-point patient-rated scale assessing perceived change in overall condition, ranging from 1 = very much improved to 7 = very much worse) scale at Week 12, compared to the placebo group.
Time frame
Baseline to Week 122
Change in Patient Global Impression of Change (PGIC) at Week 24
Percentage of participants in the Normast® 3 group reporting an improvement of at least 2 points on the Patient Global Impression of Change (PGIC) (a 7-point patient-rated scale assessing perceived change in overall condition, ranging from 1 = very much improved to 7 = very much worse) scale at Week 24, compared to the placebo group.
Time frame
Baseline to Week 243
Percentage of patients achieving Pain reduction ≥50% at Week 12
Percentage of participants achieving at least 50% reduction in average daily pain intensity (on a numerical rating scale from 0 to 10) from baseline at Week 12 in the Normast® 3 group, compared to the placebo group.
Time frame
Baseline to Week 124
Percentage of patients achieving Pain reduction ≥50% at Week 24
Percentage of participants achieving at least 50% reduction in average daily pain intensity(on a numerical rating scale from 0 to 10) from baseline at Week 24 in the Normast® 3 group, compared to the placebo group.
Time frame
Baseline to Week 24Sponsors and contacts
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Source ClinicalTrials.gov